Program Manager Clinical Research

Montefiore Health System; East Street; On-site; GBP 60,000 - 76,000; Full time

Job summary

A healthcare organization is seeking a Clinical Research Program Manager in the Bronx, NY. This role focuses on compliance and quality assurance in cancer clinical trials. Candidates should have a Bachelor's degree, significant clinical research experience, and strong communication and leadership skills. The position offers a salary range of $80,000-$100,000 and requires a commitment to excellence in clinical practices.

Qualifications

• 5 Years of work experience required.
• Minimum of 3 years of experience in clinical research.
• CCRP/CCRC Certification preferred.

Responsibilities

• Provide compliance and quality assurance reviews.
• Monitor ongoing activities including patient case reviews.
• Develop an eligibility review process for all patients.

Skills

Analytical and critical thinking skills

Demonstrated communication skills

Leadership and team building skills

Ability to prioritize and manage projects

Education

Bachelor's degree

Master's degree (preferred)

Job description

City/State: Bronx, New York

Grant Funded: Yes

Department: Cancer Clinical Trials Office

Work Shift: Day

Work Days: MON-FRI

Scheduled Hours: 9 AM-5:30 PM

Scheduled Daily Hours: 7.5 HOURS

Pay Range: $80,000.00-$100,000.00

The Clinical Research Program Manager - Monitor, under the supervision of the Director of Quality Assurance, will provide compliance and quality assurance reviews for the Montefiore Einstein Cancer Clinical Trials Office. The CRM will be responsible for all ongoing monitoring activities—patient case reviews, pharmacy reviews, regulatory reviews for Montefiore Einstein Cancer Center Investigator Initiated Trials (trials where MECC clinicians are the Sponsor Investigators/IND Holder). The CRM will provide routine reviews and determine if there are compliance concerns that warrant a formal review of the trials. The duties of this position must be executed in accordance with Good Clinical Practice (GCP) guidelines, Standard Operating Procedures (SOPs), the Montefiore Einstein Cancer Center Data and Safety Monitoring Plan (DSMP), and any other applicable regulatory requirements.

The Clinical Research Program Manager - Monitor will work under the direction of the Director, Quality Assurance and will provide constant feedback on findings and evaluation of instituted Corrective and Preventative Action Plans (CAPA).

The Clinical Research Program Manager - Monitor will serve as the Administrator for the MECC Data and Safety Monitoring Committee.

In addition, the Clinical Research Program Manager - Monitor will work with the Director, Quality Assurance to develop and support an eligibility review process for all patients enrolled on cancer clinical studies.

Requirements

• Bachelor's degree required, Master's degree preferred
• 5 Years Of Work Experience Required
• Minimum of 3 years of experience in clinical research
• CCRP/CCRC Certification preferred
• Prior experience with internal audits and/or FDA inspection preparations
• Demonstrated knowledge proficiency of and adherence to federal (FDA, OHRP, GCP, etc.), state, and other regulatory standards, requirements, and guidelines related to clinical research
• Strong working knowledge of ongoing monitoring techniques (including criteria development and trending)
• Strong working knowledge of quality management principles, tools, and risk management techniques
• Analytical and critical thinking skills to recognize trends
• Demonstrated ability to manage projects: ability to prioritize, identify barriers and meet deadlines
• Ability to prioritize, organize, plan, and implement services as well as handle multiple projects/problems simultaneously
• Demonstrated communication, leadership, and team building skills: evidence of this should include dealing well with people, effective problem solving, appropriately confronting issues, motivating others as individuals and as groups, planning, organizing, and directing the activities of others
• Demonstrated skill in working with minimal supervision
• Effective written and verbal communication

Montefiore Medical Center is an equal employment opportunity employer. Montefiore Medical Center will recruit, hire, train, transfer, promote, layoff and discharge associates in all job classifications without regard to their race, color, religion, creed, national origin, alienage or citizenship status, age, gender, actual or presumed disability, history of disability, sexual orientation, gender identity, gender expression, genetic predisposition or carrier status, pregnancy, military status, marital status, or partnership status, or any other characteristic protected by law.